Global Safety Associate Medical Director

Career Category

Safety

Job Description

The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the safety strategy and major safety deliverables for each Amgen product. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations.

Job Summary

The Global Safety Officer (GSO)   for Marketed Products   serves 2 roles: 1) safety expert of the assigned   marketed   product(s),   establishing   the strategy, direction, and priorities of pharmacovigilance activities. The GSO is accountable for the overall safety profile and all product-related decisions and deliverables for assigned   marketed   products.

The GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). The GSO also is a member of the Evidence Generation Team. The GSO will be assigned as delegate for the TAH as needed and has management of Global Safety   Scientists .

Key Activities

Applicable tasks may vary by product(s) assigned.

Product safety profile, benefit-risk evaluation, and risk communication :

Accountable for the Development and maintenance of core reference safety information ( e.g   Core safety information portions of Core Data Sheet [CDS])

Identify   relevant data and conduct benefit-risk evaluation

Participate in product label process

Clinical trial safety :

Develop a strategy as needed for preparing and updating safety related portions of the Informed Consent Form and other study related documents for trials conducted post marketing.

Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees

Perform signal detection   activities   for developmental products under the direction of the GSO leading the product in development.

Signal detection, evaluation, and management :

Develop signal detection strategy

Evaluate safety signal detection findings ,   validate   signals   and   determine   a need and develop a strategy for   further analysis

Decide on need for further actions on safety issues and lead cross-functional discussion

Documents work as   required   in the safety information management system

Prepares and presents recommendations on safety issues to the Global Safety Team and escalates as   appropriate to   the executive level cross-functional decision-making body

Approves the safety assessment report

M ay search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection

Documents work as   required   in the safety information management system

Risk management and minimization :

Ensure   timely   preparation, content, and quality of new or updated risk management plan (RMP) document

Develop a strategy for safety risk minimization measures globally (including US REMS if applicable)

Develop materials for   additional   risk minimization measures as applicable to role

Periodic (aggregate) safety reporting :

Ensure   timely   preparation and quality of periodic reports (e.g., PSUR/PBRER)

Review and approve periodic safety reports

Safety Governance Leadership :

Participates in safety governance meetings per Standard Operating Procedures and Manuals (e.g.   Facilitates , Chairs, Presents)

Amgen commercialization process :

Represents   and contributes on behalf of Global Patient Safety on Evidence Generation Teams

Inspection Readiness :

Undertake activities delegated by the QPPV as detailed in the PV System Master File and   maintain   a state of inspection readiness

Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

P artnerships and integration activities

Participate in safety agreement development and review process

Prepare safety information to support licensing partners, review safety documents prepared by licensing partners, and communicate with licensing partners on safety matters per the safety agreement

Perform safety due diligence in preparation for partnerships, etc .

Participate in integration activities

Other Amgen processes :

Interact with external stakeholders (e.g., advisory boards) on safety-related topics

Prepare for and   participate   in regulatory agency advisory committees

Provide safety input to support legal needs

Managerial and supervisory responsibilities

Oversees day to day activities of the Global Safety Physician if applicable

Ensure staff are compliant with Amgen corporate and departmental training and SOP review

Provide training, coaching, mentoring, and development of staff

Assist   in the recruitment of talented GPS and AMGEN staff

A ccountable for   disseminating   and   representing   corporate and departmental information to staff and ensuring understanding and adherence to changes

Development plans for staff created annually and reviewed quarterly

Knowledge and Skills

Processes and regulations for pharmacovigilance and risk management

Advanced understanding of interfaces across various pharmacovigilance and risk management processes

Drug development and lifecycle management

Safety data capture in clinical development and post-market settings

Safety database structure and conventions

MedDRA and other dictionaries used in pharmacovigilance

Methods of qualitative and quantitative safety data analysis

Product and disease state knowledge

General medicine, epidemiology, physiology, and pharmacology

Internal organizational and governance structure

Inter-relationship across various pharmacovigilance processes and documents, including reference safety information and product   labelling

Pharmacovigilance skills

Signal detection and evaluation

Aggregate data analysis

Good clinical and scientific judgment

Application of medical concepts and terminology

Document writing and source document review

Data interpretation and synthesis

Basic skills in application of statistical and epidemiological methods to pharmacovigilance

Ability to convey complex, scientific data in an understandable way

Ability to   analyze   and interpret complex safety data

Advanced skills in application of statistical and epidemiological methods to pharmacovigilance

O ther skills :

Strategic thinking

Effective team and strategic leadership, influencing, and negotiation in a cross-functional, matrix environment

Big picture perspective and context analysis

People and team management

Conflict management

Organization, prioritization, and planning of work

Project management

Critical scientific assessment and problem solving

Oral presentation skills

Written communications and medical/scientific writing

Computer skills (e.g., MS Office Suite and safety systems)

C ompetencies

KNOWLEDGE :

Serves as a technical authority within the organization

Develops advanced/leading-edge technologies and/or concepts that have global reach and applicability

P ROBLEM SOLVING :

Applies global thought leadership

Shapes long-term strategic direction and reputation of Amgen

Provides   authoritative advice to top management

Leads organizational invention at a global level

AUTONOMY :

Models   organizational standards for innovation

Directs projects of critical importance to Amgen

CONTRIBUTION :

Serves as expert advisor to top management and is a sponsor for large-scale projects

Ensures products and services are aligned with current and future needs and expectations including the following:

Business needs

Medical field

Research community

Creates solutions that enhance Amgen’s intellectual property

Education & Experience (Basic)

MBBS or equivalent   degree from an accredited medical school

AND

Completion of an accredited medical or surgical residency

OR

Clinical experience in either an accredited academic setting or private practice (including hospital based) setting

Education & Experience (Preferred)

MBBS   or equivalent degree from an accredited medical school

12 years of   directly related   experience OR MD of a foreign medical school

AND

Product safety in the bio/pharmaceutical industry /CRO   or regulatory agency

Previous   management and/or mentoring experience

Clinical experience in either an accredited academic setting or private practice (including hospital based) setting

.